Zanzalintinib in Men With Aggressive Variant Prostate Cancer

Conditions

• Aggressive Variant Prostate Carcinoma

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Zanzalintinib — DRUG
  Zanzalintinib 60mg orally (PO) once daily in

Study Details

This is a multi-center single arm phase II study to evaluate the antitumor activity of zanzalintinib 60mg orally (PO) once daily in subjects with AVPC. Zanzalintinib may continue until radiographic progression (or beyond), intolerable adverse events, or withdrawal of consent. As long as the subject is clinically stable, subjects may receive study treatment even after radiographic progression, until they are no longer clinically benefiting from the study treatment in the opinion of the treating Investigator, or they need subsequent systemic anticancer treatment or other urgent tumor directed medical intervention to prevent life-threatening complications. This study will use a 2-stage group-sequential design for enrollment. The first stage will consist of enrolling 15 subjects. No more than 5 of the first 15 subjects can have received chemotherapy in the castrate- resistant setting.

Key Dates

First listed

Oct 20, 2025

Start date

Jul 31, 2026

Status verified

Jul 2026

Primary completion

Jul 31, 2028

Completion

Jul 31, 2029

Study Design

Enrollment

30 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Zanzalintinib
  Zanzalintinib 60mg orally (PO) will be given once daily in subjects with AVPC.

Primary Outcome Measure

Radiographic progression free survival (rPFS) [ Time Frame: 6 months ]

Central Contacts

• Deepak Kilari, MD
  414-805-3666
  [email protected]
• Allison Lipps
  317-634-5842
  [email protected]

Locations (1)

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